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Fully automated specific protein analyzer - NMPA Registration 渝械注准20242220521

Access comprehensive regulatory information for Fully automated specific protein analyzer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20242220521 and owned by Chongqing Biostec Biological Technology Co., Ltd.. The device was approved on December 31, 2024.

This page provides complete registration details including registrant information, province location (Chongqing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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NMPA Official Data
Class II
渝械注准20242220521
Fully automated specific protein analyzer
全自动特定蛋白分析仪
NMPA Registration Number: 渝械注准20242220521
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DJ Fang

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Intended Use
English

The product is used in conjunction with matching reagents for the quantitative detection of specific proteins in human samples through scattering nephelometric dual optical path technology.

中文

该产品通过散射比浊法双光路技术,与配套的试剂共同使用,用于对人体样本中特定蛋白的定量检测。

Device Classification
Device Class
Class II
Model Specifications
BioYu
Approval Department
Chongqing Municipal Drug Administration
重庆市药品监督管理局
Registration Information
Registration Number
渝械注准20242220521
Approval Date
December 31, 2024
Expiry Date
December 30, 2029
Registrant
Name
Chongqing Biostec Biological Technology Co., Ltd.
重庆博士泰生物技术有限公司
Province/Region
Chongqing
重庆
Address
1st and 2nd floor, Building 2, No. 17, Camellia Road, Changshengqiao Town, Nan'an District, Chongqing
重庆市南岸区长生桥镇茶花路17号2幢1、2楼
Production Facility
Production Address
重庆市南岸区茶花路17号2幢1楼、2楼、3楼2-1、2-2
Structure and Composition
English

本设备由光学系统、机械运动系统、液路系统、电子控制系统和软件组成;本产品组成中的软件为外控型软件组件.

中文

本设备由光学系统、机械运动系统、液路系统、电子控制系统和软件组成;本产品组成中的软件为外控型软件组件。

Additional Information
Remark
首次注册。